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EU MDR – New Rules Require Greater Traceability, Data Transparency

Webinar Now Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.  Medical device companies are set to experience an enormous impact on all phases of the CE mark process including Design, Manufacturer Obligations, Evidence Collection, Conformity Assessment, Registration and Post Market Surveillance and Vigilance.

The schedule is aggressive – the rules will apply to some previously unregulated products and there will be no grandfathering of previously approved medical devices.  Controls on notified bodies that can approve the marketing of medical devices and the reporting on clinical trials will also be tightened.  Once devices are available for use on the market, manufacturers will be obligated to collect performance data to support tighter post-market surveillance requirements.  In addition, a new system will apply to in vitro diagnostic medical devices.

Concerns are quickly mounting throughout the industry.  We interviewed executives to determine what steps they were taking to prepare for the looming May 2020 deadline.  We heard:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “Our challenge is showing management what the cost is per product from a compliance standpoint”
  • “Imagine tracking down paper records for products from the 60s and 70s!”
  • “We will probably have to do a complete revamp of technical files to do resubmission”
  • “Our organization is behind on the IT curve. It will likely take three to four years to implement a robust global product data management system like that to support EU MDR”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

In a recent webinar sponsored by Sparta Systems, we discussed why Digital Transformation is a necessary journey for EU MDR compliance and beyond. The recording is now available on-demand.

It is important to note that MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both EU MDR and IVDR until full readiness of the system has been achieved.”  However, Med-Tech companies must begin to take a long view on EU MDR now and begin their digital transformation journey to support EU MDR and beyond.

Is your organization ready to achieve sustainable, positive disruption? Contact us today.

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